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Up to $24M Will Be Invested in the Novel “Nano-formulated Taxane”

For the past few decades, Stony Brook University Distinguished Professor Iwao Ojima has been working in his chemistry laboratory and through the Institute of Chemical Biology & Drug Discovery (ICB&DD) to develop next-generation anti-cancer agents. One of these agents — a second-generation taxane conjugate in a nanoemulsion formulation (called NE-DHA-SBT-1214) — has shown great promise against solid tumors, particularly against colorectal cancer. In 2016, the taxane compounds were licensed to a Stony Brook University spinout, TargaGenix, Inc., to advance their development toward clinical use. Since then, TargaGenix has further developed the compounds, addressing formulation, toxicity and in vivo efficacy, and has now attracted significant investment in NE-DHA-SBT-1214.

Ojimagrouplicensing23Iwao Ojima (center) developed a second-generation taxane formulation that shows such promise to treat cancer that the compound has been licensed for product development. Also pictured are Sean Boykevisch, director of Stony Brook’s Intellectual Property Partners (left) and James E. Egan, CEO of TargaGenix.  Photo Credit: John Griffin, Stony Brook University

TargaGenix plans to work with its partners to develop the new taxane as a stand-alone drug, as well as look to use it in combination with other treatment modalities, including immune-oncology agents. The company and its collaborators expect to advance the drug development into clinical testing in humans in the near future.

TVM Capital Life Science (TVM) is committing up to $24 million for a development program to help advance NE-DHA-SBT-124 to market as an alternative medicine to treat colorectal cancer and other solid tumors.

Taxanes are a class of oncology drugs widely used to treat solid tumors. They are represented by paclitaxel, docetaxel and cabazitaxel. The drug class inhibits tumor growth by blocking cancer cell mitosis. However, multidrug resistance (MDR) and cancer stem cells (CSCs), along with various adverse effects, often hamper the effective use of these drugs. Ojima and his team developed a highly potent second-generation taxane conjugated to DHA (a widely known omega-3 fish oil supplement) in nanoemulsion formulation. The agent (NE-DHA-SBT-1214) exhibited not only excellent activity against MDR solid tumor xenograft models, but also against CSC-initiated tumor xenografts models.

“A primary indication for NE-DHA-SBT-1214 is colorectal cancer, which is a very challenging cancer to deal with due to strong multidrug resistance,” said Ojima. “But it also shows promise with pancreatic cancer and prostate cancer in preclinical testing. For example, we examined NE-DHA-SBT-1214 in combination with PLD-1 antibodies for pancreatic cancer. The combination therapy exhibited superior results over the current best standard treatment against this deadly disease.”

The new taxane conjugate is formulated using a nanotechnology called nanoemulsion, originally developed by Mansoor Amiji at Northeastern University. This nano-formulation together with DHA conjugation allows for tumor-selective drug delivery by means of an “Enhanced Permeability and Retention (EPR)” effect characteristic to nano-size particles, as well as a controlled release of highly potent second-generation taxane. This has been shown in preclinical testing to make the taxane efficacious against MDR and CSCs within the tumor.

“The novel taxane originally developed by Dr. Ojima and his team shows great promise in pre-clinical studies of colorectal and pancreatic cancer, two of the deadliest cancers in humans. I am delighted that after decades of research, the drug will be entering clinical trials in patients. This example illustrates the importance of research in Stony Brook’s basic science departments for developing new potential treatments for cancer,” said Peter Igarashi, MD, dean of the Renaissance School of Medicine at Stony Brook University.

“I couldn’t be more pleased for Iwao for this exciting achievement,” said Nicole S. Sampson, dean of the College of Arts and Sciences and distinguished professor of chemistry. “I have watched this research project unfold since the very early stages, and this program highlights chemistry’s impact on innovation — how fundamental molecular science can be applied to solve really intractable problems like colorectal cancer — and would not have happened without Iwao’s dedication, perseverance and commitment to excellence in science. We are fortunate to have him as a colleague, entrepreneur and mentor in the Department of Chemistry!”

“Taxanes have been a cornerstone of cancer treatment for decades, but they can come with significant side effects, and treated cancers frequently recur,” said James E. Egan, CEO of TargaGenix. “We are excited to have TVM’s strong support and to now have the resources to further the development of this potentially game-changing molecule,” added Egan, who received his PhD at Stony Brook University in molecular pharmacology.

Stony Brook University’s Intellectual Property Partners (IPP) worked with TargaGenix to secure TVM’s investment.

“My office worked closely with James and TVM through this investment, and we are elated to see it close,” said Sean Boykevisch, director of IPP. “The funding will accelerate this new potential therapeutic into the clinic, where we hope it will provide meaningful clinical responses and potentially become a new standard of care.”

About TVM Capital Life Science

TVM is a leading international venture capital firm focused on investing in life science innovations. The company has a highly experienced transatlantic investment team and approximately $900 million under management. TVM’s portfolio focuses on therapeutics and medical technologies from North America and the EU that represent differentiated first-in-class or best-in-class assets with the potential to transform standard of care.

TVM pursues a unique two-pronged strategy, financing innovative early-stage therapeutics through a single asset company approach that leverages the firm’s strategic relationship with global pharmaceutical firm, Eli Lilly and Company. TVM also invests in differentiated commercial-stage medical technologies and late clinical-stage therapeutics.

With its early-stage investments, TVM follows several key principles, which include increasing capital efficiency, streamlining development timelines and soliciting buyer input at the time of investment. This strategy has been validated through successful exits such as AurKa Pharma, Inc. and Acanthas Pharma, Inc.

The TVM investment team has worked together for more than a decade to effectively utilize this innovative approach to maximize returns for investors and finance new therapies and technologies to meaningfully improve patient lives.